FDA-Device2017-12-20Class II
enGen Track System with TCAutomation Software Version 4.2
Ortho-Clinical Diagnostics
Hazard
A software anomaly with TCA Software V4.2 may potentially cause a delay in reporting of results due to patient samples being routed to an unintended location when samples are reintroduced back onto the enGEN track
Sold states
Domestically - GA, IL, MO, NC & NY; Internationally - Canada, England, France, Italy & Spain
Affected count
16
Manufactured in
100 Indigo Creek Dr, N/A, Rochester, NY, United States
Products
enGen Track System with TCAutomation Software Version 4.2
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0254-2018Don't want to check this manually?
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